NCT01201616

Brief Summary

A previous study has found that the consumption of a high fat, low carbohydrate meal results in increased feelings of calmness, friendliness and an increase in subjective energy levels in comparison to a low fat, high carbohydrate meal. The purpose of this study is to investigate whether a high fat, low carbohydrate diet for a longer duration (of 2 weeks) can enhance or sustain these changes in comparison to a low fat, high carbohydrate meal.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

March 27, 2018

Status Verified

March 1, 2018

Enrollment Period

2.4 years

First QC Date

September 13, 2010

Last Update Submit

March 23, 2018

Conditions

Keywords

Cognitive functionmoodwomenhigh fat diethigh carbohydrate diet

Outcome Measures

Primary Outcomes (1)

  • Clear-headedness

    Subjective mood measurement, assessed using visual analogue scale, in response to a test meal

    after 2 week intervention period

Secondary Outcomes (1)

  • Reaction time

    after 2 week intervention

Study Arms (2)

High fat, low carbohydrate diet

EXPERIMENTAL

Fats intake 55% , Protein 17% and carbohydrate 28% of total energy

Other: High Fat Low Carbohydrate Diet

Low fat, high carbohydrate diet

ACTIVE COMPARATOR

Fat intake 20%, Protein 17% and carbohydrate 63% of total energy intake

Other: Low fat High Carbohydrate Diet

Interventions

55% total energy intake from fats, 17% from protein and 28% from carbohydrate

Also known as: HFLC Diet
High fat, low carbohydrate diet

20% total energy intake from dietary fats, 17% from protein and 63% from carbohydrate

Also known as: LFHC Diet
Low fat, high carbohydrate diet

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female
  • BMI 18.5-25kg/m2
  • aged 18-45 years
  • regular breakfast eaters
  • regular menstrual cycle
  • healthy

You may not qualify if:

  • Significant gastrointestinal disease, gastrointestinal surgery, diabetes or any other significant major medical morbidity
  • History of significant eating disorder (anorexia, bulimia)
  • Habitual dietary protein intake \>20% of total energy intake
  • pregnancy or breast feeding
  • anaemia (Hb \<11.5g/dL)
  • random blood glucose concentration \>8mmol/l
  • no medication use other than contraception
  • significant weight loss/gain (\>14lb in previous 3 months)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Nottingham

Nottingham, Notts, NG72UH, United Kingdom

Location

Related Publications (2)

  • Benton D, Parker PY. Breakfast, blood glucose, and cognition. Am J Clin Nutr. 1998 Apr;67(4):772S-778S. doi: 10.1093/ajcn/67.4.772S.

    PMID: 9537627BACKGROUND
  • Pollitt E, Mathews R. Breakfast and cognition: an integrative summary. Am J Clin Nutr. 1998 Apr;67(4):804S-813S. doi: 10.1093/ajcn/67.4.804S.

    PMID: 9537633BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Ian A Macdonald, PhD

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Research Fellow

Study Record Dates

First Submitted

September 13, 2010

First Posted

September 14, 2010

Study Start

July 1, 2010

Primary Completion

December 1, 2012

Study Completion

March 1, 2013

Last Updated

March 27, 2018

Record last verified: 2018-03

Locations